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dc.contributor.authorChen, LT
dc.contributor.authorSiveke, JT
dc.contributor.authorWang-Gillam, A
dc.contributor.authorLi, CP
dc.contributor.authorBodoky, G
dc.contributor.authorDean, AP
dc.contributor.authorShan, YS
dc.contributor.authorJameson, GS
dc.contributor.authorMacarulla, T
dc.contributor.authorLee, KH
dc.contributor.authorCunningham, D
dc.contributor.authorBlanc, JF
dc.contributor.authorChiu, CF
dc.contributor.authorSchwartsmann, G
dc.contributor.authorBraiteh, FS
dc.contributor.authorMamlouk, K
dc.contributor.authorBelanger, B
dc.contributor.authorde Jong, FA
dc.contributor.authorHubner, Richard A
dc.date.accessioned2018-12-10T11:48:55Z
dc.date.available2018-12-10T11:48:55Z
dc.date.issued2018en
dc.identifier.citationChen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP, et al. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial. Eur J Cancer. 2018 Dec;105:71-8.en
dc.identifier.pmid30414528en
dc.identifier.doi10.1016/j.ejca.2018.09.010en
dc.identifier.urihttp://hdl.handle.net/10541/621410
dc.description.abstractBACKGROUND: In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population. MATERIALS AND METHODS: The PP population comprised patients receiving ?80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed. RESULTS: For PP patients, median OS was 8.9 (95% confidence interval: 6.4-10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0-7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3-5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7-3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648). CONCLUSION: A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.ejca.2018.09.010en
dc.titleSurvival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a globalphase 3 trial.en
dc.typeArticleen
dc.contributor.departmentNational Institute of Cancer Research, National Health Research Institutes (NHRI), 367 Sheng-Li Road, Tainan 704, Taiwanen
dc.identifier.journalEuropean Journal of Canceren


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